BEUDAMED
    25 results · 27ms · Sources: EU EUDAMED, US FDA

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    ND YAG Q-switch Laser Therapy Machine

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MEDISLIM

    FDA Adverse Event
    Injury ·MEDICREATIONS, LLC·Product code GEX·April 27, 2020

    CORONIS 2MP AND MDCG 2121 - CB

    FDA 510(k)
    FDA Class 2 ·Radiology

    FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FREESTYLE LITE

    FDA Adverse Event
    Malfunction ·Product code NBW·July 25, 2012

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 10, 2014

    ICEMAN THERAPY UNIT

    FDA Adverse Event
    Injury ·DJ ORTHOPEDICS DE MEXICO·Product code ILO·July 11, 2011

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 11, 2013

    Cardiac Science Powerheart 9390A automated external defibrillator. This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when appropriate). Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·November 13, 2009

    Cardiac Science Powerheart 9300P automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·November 13, 2009

    Cardiac Science Powerheart 9390E automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·November 13, 2009

    Burdick Cardiovive 92532 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·November 13, 2009

    Cardiac Science Powerheart 9300C automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·November 13, 2009

    NK 9231 CardioLife automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·November 13, 2009

    GE Responder 2019198 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·November 13, 2009

    GE Responder 2023440 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·November 13, 2009

    Cardiac Science Powerheart 9300E automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·November 13, 2009

    Burdick Cardiovive 92531 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·November 13, 2009

    Cardiac Science Powerheart 9300A automated external defibrillator. This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when appropriate). Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·November 13, 2009

    NK 9200G. CardioLife automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Intended for use in either in-hospital or out-of-hospital settings for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·November 13, 2009